Short-course Preoperative Chemoradiotherapy for Rectal Cancer (KROG 11-02)

This study is currently recruiting participants.
Verified September 2011 by Seoul St. Mary's Hospital
Seoul National University Hospital
Samsung Medical Center
National Cancer Center, Korea
Information provided by (Responsible Party):
Jong Hoon Lee, Seoul St. Mary's Hospital Identifier:
First received: September 6, 2011
Last updated: September 9, 2011
Last verified: September 2011

The purpose of this study is to evaluate the early clinical outcome of the short-course preoperative chemoradiotherapy, 33Gy/10 fx and delayed operation after chemoradiation, the investigators initiated the clinical trial of KROG 11-02.

Condition Intervention Phase
Rectal Cancer
Radiation: short-course radiation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Two Week-course Preoperative Chemoradiotherapy Followed by Delayed Operation for Rectal Cancer: Phase II Multicenter Clinical Trial (KROG 11-02)

Resource links provided by NLM:

Further study details as provided by Seoul St. Mary's Hospital:

Primary Outcome Measures:
  • downstaging effect of tumor [ Time Frame: an expected average of 6 weeks after chemoradiation ] [ Designated as safety issue: No ]
    Comparison of clinical T staging and pathologic T staging example> cT4 --> pT1 after chemoradiation: down staging (+)

Secondary Outcome Measures:
  • bladder and small bowel toxicity after chemoradiation [ Time Frame: Participants will be followed for an expected average of 3 months after chemoradiation ] [ Designated as safety issue: Yes ]
    The incidence of grade 3 or higher small bowel and bladder toxicity according to the RTOG and EORTC toxicity criteria (reference: Cox JD et al. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1341-6)

Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: short-course Radiation: short-course radiation
33Gy/10 fractions


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. histologically confirmed adenocarcinoma
  2. distal margin of the tumor located < 8 cm above the anal verge
  3. cT3-4 or cN+ classification as determined by endorectal ultrasonography (EUS) and CT
  4. patient older than age 18 years
  5. Karnofsky performance score >= 70

Exclusion Criteria:

  1. distant metastasis identified during staging workup
  2. previous or concurrent malignancy
  3. pregnant or breast-feeding women
  4. impending rectal obstruction
  5. familial adenomatous polyposis
  Contacts and Locations
Please refer to this study by its identifier: NCT01431599

Contact: Jong Hoon Lee, MD 82-010-8607-1269

Korea, Republic of
National Cancer Center, Korea Recruiting
Goyang, Korea, Republic of
Contact: Dae Yong Kim, MD   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Eui Kyu Chie, MD   
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Hee Chul Park, MD   
Sponsors and Collaborators
Seoul St. Mary's Hospital
Seoul National University Hospital
Samsung Medical Center
National Cancer Center, Korea
Principal Investigator: Hong Seok Jang, MD Department fo Radiation Oncology, Seoul St. Mary's Hospital
  More Information

Responsible Party: Jong Hoon Lee, Dr., Seoul St. Mary's Hospital Identifier: NCT01431599     History of Changes
Other Study ID Numbers: KROG 11-02
Study First Received: September 6, 2011
Last Updated: September 9, 2011
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Seoul St. Mary's Hospital:
Locally advanced rectal cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases processed this record on April 16, 2014